Hemorrhoidal Cream

Manufacturer
Trifecta Pharmaceuticals Usa Llc
Effective date
2025-11-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:16:45

Label at a glance#

ProductHemorrhoidal Cream
Active ingredientPRAMOXINE HYDROCHLORIDE, PETROLATUM, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure21 sections

Indications and uses

Helps relieve the local itching and discomfort associated with hemorrhoids Temporarily shrinks hemorrhoidal tissue and relieves burning Temporarily provides a coating for relief of anorectal discomforts Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Dosage and administration

Adults: When practical, clean the affected area by patting or blotting with an appropriate cleaning wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream. When first opening tube, puncture foil seal with top end of cap Apply externally or in the lower portion of the anal canal only Apply externally to the affected area up to 4 times daily, especially at night, in the morning or ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Glycerol 14.4%

Purpose

OTC - PURPOSE SECTION

Protectant

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCI 0.25%

Purpose

OTC - PURPOSE SECTION

Vasoconstrictor

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCI 1%

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 15%

Purpose

OTC - PURPOSE SECTION

Protectant

Uses

INDICATIONS & USAGE SECTION

Helps relieve the local itching and discomfort associated with hemorrhoids

Temporarily shrinks hemorrhoidal tissue and relieves burning

Temporarily provides a coating for relief of anorectal discomforts

Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Stop use and ask a doctor

OTC - STOP USE SECTION

Bleeding occurs

Condition worsens or does not improve within 7 days

An allergic reaction develops

The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

If Pregnant or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask doctor before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults:

When practical, clean the affected area by patting or blotting with an appropriate cleaning wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream.

When first opening tube, puncture foil seal with top end of cap

Apply externally or in the lower portion of the anal canal only

Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

Warnings

WARNINGS SECTION

For External Use Only

Ask doctor brfore use if you have

Heart Disease

Thyroid Disease

Diabetes

Trouble urinating due to an enlarged prostate gland

Ask doctor before use if you are presently taking a prescription for high blood pressure or depression

When using this product

Do not exceed the recommended daily dosage unless directed by a doctor

Do not put into the rectum by using fingers or any mechanical device or applicator

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature 20º-25ºC (68º-77ºF)

Do not use if tube seal is broken or missing

This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H®

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, carboxmethylcellulose sodium, cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, polysorbate 80, propylene glycol, propylparaben, purified water, stearic acid, xanthan gum

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Distributed By

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301, USA

1-888-296-9067

Product of PRC

www.trifecta-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hemorrhoidal CreamHemorrhoidal Cream

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

403903-FBA GLOBE HEMORRHOIDAL CREAM WITH ALOE 1.8OZ 3PK_BOX 031925 CDER403903-FBA GLOBE HEMORRHOIDAL CREAM WITH ALOE 1.8OZ 3PK_BOX 031925 CDER

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

430902-FBA GLOBE HEMORRHOIDAL CREAM WITH ALOE 1.8OZ 2PK_BOX 080625-JW430902-FBA GLOBE HEMORRHOIDAL CREAM WITH ALOE 1.8OZ 2PK_BOX 080625-JW

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSN6
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD6
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130040232622830GTIN-13: 0040232622830
EAN-13: 0040232622830
GTIN-12: 040232622830
UPC-A: 040232622830
GTIN storage (14 digits): 00040232622830
globe hemorrhoidal cream with aloe@2x-50.jpg
Data codeCode 128X0045DX1A5403903-FBA GLOBE HEMORRHOIDAL CREAM WITH ALOE 1.8OZ 3PK_BOX 031925 CDER.jpg
Data codeCode 128X004S6C3QH430902-FBA GLOBE HEMORRHOIDAL CREAM WITH ALOE 1.8OZ 2PK_BOX 080625-JW CD....jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-033-18Hemorrhoidal Cream1 in 1 BOXCREAM16
69396-033-18Hemorrhoidal Cream51 g in 1 TUBECREAM516
69396-033-22Hemorrhoidal Cream2 in 1 BOXCREAM26
69396-033-22Hemorrhoidal Cream51 g in 1 TUBECREAM516
69396-033-33Hemorrhoidal Cream3 in 1 BOXCREAM36
69396-033-33Hemorrhoidal Cream51 g in 1 TUBECREAM516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-033-18GM - Gram69396-0333d4c31f2-e908-4570-b893-d7e995d1eb9812024-04-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-03369396-033-18, 69396-033-33, 69396-033-22

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
ndc (package): 69396-033-18
ndc (package): 69396-033-22
ndc (package): 69396-033-33
ndc (product): 69396-033
ndc11 (package): 69396003318
ndc11 (package): 69396003333
ndc11 (package): 69396003322
spl id: 43e0c50f-9d84-3f1c-e063-6394a90a9a23
spl set id: 804d7b1f-1be8-50c9-e053-2a91aa0a35d0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.